Oncoxin® and Quality of Life in Cancer Patients

Non-small Cell Lung Cancer Stage III Clinical Trial

Official title:

ONCOXIN® and Quality of Life in Cancer Patients in a Real World Setting Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03550482
• Other study ID #: OOS-CANCER-5
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2017
• Est. completion date: May 15, 2019

Study information

• Verified date: May 2018
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is expected that additional support with certain micronutrients may improve prognosis, decrease the frequency of side effects and complications and maintain high relative dose intensity of anticancer treatments. Food supplement ONCOXIN (ONCX) contains amino acids, vitamins, minerals and biologically active substances of natural origin with high immunostimulatory and antioxidant activity. Present study is a real world experience study intended to evaluate the efficacy of ONCX in cancer patients.

Description:

The study was conducted at 9 centers across the Russia and Kazakhstan. Patients were allocated in 2:1 comparison groups for the ONCX and control groups, respectively. A total of 133 patients were enrolled in the study; 84 in the ONCX group and 49 as controls.

ONCX contains microelements, vitamins, amino acids and certain naturally occurring, biologically active substances.

It is expected that additional support with certain micronutrients may improve prognosis, decrease the frequency of side effects and complications and maintain the Quality of life in cancer patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: May 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Male and female patients who had signed an informed consent.

2. Males and females aged 50-70 y/o

3. Gastric cancer IIB-IIIC, Non-small cell lung cancer IIB-IIIA

4. R0 surgery

5. Adjuvant chemotherapy (ACT) required, 2nd and further course of ACT, XELOX regimen of ACT for gastric cancer and paclitaxel+carboplatin regimen for non-small cell lung cancer.

6. Body mass index (BMI) = 15, serum albumin = 25 g/l.

7. Eastern Cooperative Oncology Group performance status = 2

Exclusion Criteria:

1. Severe concomitant diseases or conditions that may complicate or make impossible the patient's participation in the study, or make it difficult to interpret the clinical data (including mental disorders, severe infectious and parasitic diseases and intolerability to any of the ONCX components).

2. The patient's family or official relations with a member of staff of the study center.

3. The patient's failure to assess his/her physical and/or emotional condition.

4. The patient's failure to comply with the study requirements.

5. The patient's refusal to participate in the study and pregnancy or lactation.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Gastric Cancer Stage II
• Gastric Cancer Stage III
• Lung Neoplasms
• Non-small Cell Lung Cancer Stage II
• Non-small Cell Lung Cancer Stage III
• Stomach Neoplasms

Intervention

Dietary Supplement:
• ONCOXIN®
Adjuvant chemotherapy regimen (XELOX or paclitaxel+carboplatin) + Oncoxin 25 ml twice daily for 20 days. In case of nausea/vomiting after ONCX use patients were advised to dilute it in water, juice or milk. Patients with BMI <20 and serum albumin levels <30 g/l received nutritional support.

Locations

Country	Name	City	State
Kazakhstan	Kazakh Research Institute of Oncology and Radiology	Almaty
Kazakhstan	State Municipal Enterprise on the Right of Economic Management "Almaty Oncology Center" of Almaty Healthcare Administration	Almaty
Russian Federation	Medical Center "EVIMED" LLC	Chelyabinsk
Russian Federation	State-funded Healthcare Institution Oncologic Clinical Dispensary No.1	Moscow
Russian Federation	The Loginov Moscow Clinical Scientific Center, www.mknc.ru	Moscow
Russian Federation	Medical University "Reaviz"	Samara
Russian Federation	Non-government Healthcare Institution " Hospital of JSC Russian Railways Hospital at the Station Smolensk	Smolensk
Russian Federation	State-funded Institution "Surgut Regional Hospital"	Surgut
Russian Federation	State-funded Institution of Khanty-Mansiysk Regional Clinical Hospital	Ugra	Tyumen Region

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Countries where clinical trial is conducted

Kazakhstan,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life improvement	The proportion of patients who had an improvement in the QoL corresponding to the minimal clinically important difference (MCID) that any patient was able to feel at Visits 2 in total SDS ESAS (6 points within patient change for improvement)	20 days
Secondary	Emotional Quality of life	emotional SDS ESAS domains	20 days
Secondary	Toxicity produced by Chemotherapy	Common toxicity criteria NCI-CTC. Common Terminology Criteria for Adverse Events (AE) is a descriptive terminology which can be utilized for Adverse Event reporting. A grading (severity) scale is provided for each AE term.	20 days
Secondary	Toxicity produced by Chemotherapy	Body Mass Index (BMI) combined with albumin. High body mass index (BMI) has been inconsistently associated with overall survival. Preoperative body mass index, blood albumin and triglycerides predict survival for patients with gastric cancer.	20 days
Secondary	Physical Quality of Life	Physical SDS ESAS scores	20 days
Secondary	Nutritional level	Serum albumin level measures	20 days